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Debate Persists on Engineering Avian Flu Strains

A German worker on Feb. 16 cleanses a duck farm that experienced an avian influenza outbreak. Scientists attending a biodefense conference on Monday continued to pose questions about research that increased the transmissibility of the H5N1 virus (AP Photo/Patrick Pleul).

WASHINGTON -- Numerous questions persist on the specifics of conducting and publishing research that deliberately modifies the avian influenza virus to be more contagious among humans, scientists said at a gathering on Monday.

The international flu research community last month ended a one-year voluntary moratorium on "gain-of-function" studies involving the H5N1 virus. The pause took effect after a U.S. panel of biosecurity experts urged two scientific journals not to publish certain data from two studies that genetically modified avian flu to be more transmissible between ferrets; the specialists amended their recommendation after receiving clarifying details, and publication of the unredacted U.S. and Dutch manuscripts took place later in 2012.

The United States last week issued new standards governing federally funded H5N1 gain-of-function studies, as well as draft guidelines for institutions overseeing of wider array of biological experimentation that might pose a threat to the populace.

Still, one member of the U.S. advisory board said the scientific community had yet to articulate "a cogent case for gain-of-function experiments."

It remains unclear "whether the same information can be obtained by other means," said Arturo Casadevall, a microbiologist and member of the National Scientific Advisory Board for Biosecurity.

To date, though, such studies "have been critical for establishing the potential for H5N1 to acquire mammalian transmissibility," Casadevall said at an American Society for Microbiology research meeting on biodefense and emerging diseases. "No matter what you say, we did not know this before," he said.

In considering the two studies, the board agreed on the importance of developing mechanisms to oversee sensitive biological studies and disseminate resulting scientific data, added Columbia University microbiologist Michael Imperiale, another NSABB member. U.S. officials informed the panel then that no "credible" proposals existed for such control procedures, but "there were still ongoing efforts to try to deal with these types of issues in the future," he said in an address to conference participants.

Imperiale also described a need for a "more concrete" method of weighing the threats and possible gains of various sensitive biological research proposals.

Barbara Jasny, an editor for the journal Science, voiced similar concerns. Her journal published the controversial H5N1 study conducted at Erasmus Medical Center in the Netherlands.

"It was very difficult for the journals to get information that would help us to do a risk-benefit analysis and to proceed in a responsible manner," Jasny said.

"Does the fact that Science and Nature publish these sorts of papers drive more labs to work in this area that aren't justified given the safety concerns?" she asked. "I don't have an easy answer for that."

Imperiale stressed the critical role that the free flow of information plays in the scientific process, but added "we live in a very different world than the world we've been used to publishing open in."

"No one has come up with a good way to share redacted information to date, [but] maybe we shouldn't keep that to not keep thinking about it," he said.

Imperiale said the H5N1-specific review framework unveiled last week attempts to "remove some of that subjectivity from the process."Under the new rules, a potential study in part must address an area of inquiry with major medical implications and include adequate measures to minimize threats.

However, similar concerns might arise over comparable studies involving other infectious agents, and international collaboration is necessary to pursue global standards on the matter, Imperiale said.

H5N1 has so far been relatively slow to spread in humans, but the virus has killed more than half of those infected. Of the 610 confirmed human bird flu cases, 360 have ended in death, the World Health Organization indicated in a Jan. 16 statement.

Casadevall described bird flu as "an existential threat to humanity," and argued that "the influenza research establishment remains humanity's best defense against the calamity of a new pandemic."

The federal biodefense board's concerns about the research shifted in 2012 from worries that a malevolent actor might obtain a more virulent form of the virus to the potential for "these things [to] get out of a lab and cause an outbreak themselves," Casadevall added.

The scientist declined to specify what factors prompted the change in emphasis. He cited only a consensus that emerged within the body through a gradual "deliberative process."

Jasny described a general agreement among specialists that "H5N1 would not make a good bioweapon."

"If you had anyone with any expertise involved in this, they would know that the virus spreads indiscriminately, that it's no easy to engineer and it's not very stable. But ... maybe the terrorists wouldn't be so smart, maybe we would have crazy doomsday individuals," she said.

February 25, 2013

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WASHINGTON -- Numerous questions persist on the specifics of conducting and publishing research that deliberately modifies the avian influenza virus to be more contagious among humans, scientists said at a gathering on Monday.